Kornimate/medical-research-clean huggingface dataset:
pre- vs postoperative thromboprophylaxis for liver resection

Conditions: Liver Cancer; Surgery; Thrombosis, Deep Vein; Embolism, Pulmonary; Bleeding

Summary: thromboprophylaxis for liver surgery can be commenced either preoperatively or postoperatively. despite a clear trade-off between thrombosis and bleeding in liver surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing liver surgery. as far as we know, there are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. both american and european thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with liver surgery. on the contrary, dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. traditionally, many liver surgery units have been reluctant in using preoperative thromboprophylaxis due to the potentially increased risk of bleeding complications. enhanced recovery after surgery (eras) society guidelines recommend preoperative thromboprophylaxis in liver surgery, but the guidelines provide no supporting evidence for this recommendation. overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in liver surgery. the aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in liver surgery in a randomized controlled trial.


Eligibility criteria:
inclusion criteria: * all patients undergoing liver resection exclusion criteria: * patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during last month pre-surgery * emergency operation (e.g. for trauma or infection) * age \< 18 years * allergy or other contraindication to planned low-molecular weight heparin * inability to give written informed consent * liver resection not performed (removed from analyses after randomization)
evaluation of the performance of a fungal nail treatment on the visual signs of onychomycosis

Conditions: Onychomycosis of Toenails

Summary: this is a prospective, open label, non-comparative clinical investigation to evaluate the performance of a fungal nail treatment on the visual signs of onychomycosis. the fungal nail treatment is a ce marked class i medical device and is commercially available as an over-the-counter product. the ability of the fungal nail treatment to treat the visual signs of mild fungal toenail infections will be determined by a reduction in the surface area of the infection over time. this will be assessed through visual quantification of the infected area from baseline, as measured by image analysis, throughout the treatment period, where subjects will follow instructions for use on the product pack and self-treat for the duration of the investigation or until their condition has resolved. both subject and podiatrist will assess the improvement of signs and symptoms of the target nail.


Eligibility criteria:
inclusion criteria: * informed consent has been obtained. * age between 18 years to 65 years inclusive. * gender: male and female subjects. * subjects with visual signs of mild fungal nail infection present on at least one big toenail or with fungal nail infection on one other toenail on the same foot, in addition to the target big toenail (condition of other foot not relevant) as per podiatrist visual assessment. * subjects with no more than 50% surface area of the target big toenail visually affected, from the leading distal edge, as assessed by the podiatrist. exclusion criteria: * subjects with moderate to severe fungal toenail infection, on either big toenail, as determined by podiatrist assessment. * subjects with fungal nail infection on more than two toenails on their target foot. * subjects reporting presence of visual symptoms of fungal toenail infection for more than five years.

Keywords: fungal nail
post marketing surveillance study to observe safety and efficacy of aromasin in the patients with early or advanced breast cancer

Conditions: Breast Cancer

Summary: this non-interventional study is to monitor use in real practice in korea including adverse events on aromasin (exemestane).

all cases at the participating institutions.

Eligibility criteria:
inclusion criteria: * - postmenopausal women with breast cancer eligible for hormonal therapy. exclusion criteria: * pregnant breast-feeding premenopausal.
a study of the safety, tolerability and pharmacokinetics of medi0618 in healthy volunteers

Conditions: Chronic Pain

Summary: this is a randomised, placebo-controlled study of the safety and tolerability of single doses of medi0618 in healthy volunteer subjects.

this is a randomised, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of single ascending doses of medi0618 in healthy male and female volunteers. this study will include 9 planned cohorts; 8 cohorts will receive single ascending doses of medi0618 or placebo by intravenous administration, 1 cohort will receive medi0618 or placebo by subcutaneous administration.all subjects will undergo scheduled safety, tolerability, pharmacokinetic and immunogenicity assessments while in the clinical unit and as outpatients to the end of the follow-up period.

Eligibility criteria:
inclusion criteria: * healthy men and women of non-childbearing potential aged 18 to 55 years * normal 12-lead ecg at screening and on day of dosing * physical examinations with no significant findings at screening * be able to understand and comply with protocol requirements exclusion criteria: * participation in another clinical study with an investigational product (ip) within half-lives of the ip or 3 months, whichever is longer, prior to screening * requires treatment with another biological therapeutic agent * inability to comply with study-related requirements * history of severe allergy or hypersensitivity reactions * history of significant psychiatric disorder * presence of any clinically significant illness * history of cancer * any clinically important abnormality physical examination, vital signs, ecg or laboratory test

Keywords: double-blind placebo-controlled safety and tolerability study healthy volunteers
evaluation of fid 114657 in dry eye subjects

Conditions: Meibomian Gland Dysfunction

Summary: the primary objective of this study is to assess the overall meibomian gland dysfunction subject's preference for a particular product. dry eye symptom relief will also be evaluated based on clinical evaluation and a set of subject questionnaires.


Eligibility criteria:
inclusion criteria: * patients must be at least 18 years of age * must read and sign the informed consent forms (icf) * must agree to comply with the study requirements. * patients must have a best corrected visual acuity of 0.6 logmar or better in each eye * must report having an ocular examination in the last two years * must be using topical ocular dry eye therapy (artificial tears or restasis® at least 2 times per day. * must have been diagnosed with meibomian gland dysfunction / posterior blepharitis based on the following criteria: must have dry eye symptoms and meibomian gland expression grade greater than 1. exclusion criteria: * patients cannot wear contact lenses during the study and cannot have a history of hypersensitivity to any component of fid 114657. * patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have a history and/or current evidence of active intraocular inflammation in either eye. * patients cannot have punctal plugs that were placed less than or equal to 30 days prior to visit 1, and they cannot have ocular conditions that, in the opinion of the investigator, preclude the safe administration of the test article. * they cannot have started or changed the dose of chronic systemic medication within 7 days prior to visit 1, and must remain on a stable dosing regimen for the duration of the study. * patients cannot have participated in another investigational clinical or research study within 30 days of visit 1. * subjects cannot have a history and/or current evidence of the following: epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; active ocular rosacea (excluding subjects enrolled with mgd (posterior blepharitis)); acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal diseases of the eye.

Keywords: meibomian gland dysfunction dry eye
a study to evaluate effects of gargle phonation in voice

Conditions: Voice Disorders; Muscle Tension Dysphonia; Speech Therapy

Summary: the purpose of this study is to assess subjects with muscle tension dysphonia for perceived effort and acoustic effects of gargle phonation compared to baseline and a sham water swallow.

this study assesses perceived effort following baseline talking, water swallows and gargle phonation. in addition to perceived effort, acoustic and perceptual analyses will be conducted on the recorded voice samples using vowel sounds, the consensus auditory-perceptual evaluation of voice (cape-v) and hearing in noise sentences (hint).

Eligibility criteria:
inclusion criteria: * patients must have a primary or secondary muscle tension dysphonia based clinical assessment with a mayo clinic speech language pathologist or other mayo clinic otolaryngology care provider in rochester or phoenix/scottsdale locations. * age 18 through 89. * able to provide informed consent. exclusion criteria: * anyone not meeting inclusion criteria. * anyone unable or unwilling to provide informed consent. * anyone unable to complete questionnaires or participate in voice recording. * anyone with severe neurological voice or speech disorders. * moderate or severe dysphagia for thin liquids. * non-english speakers (english as a second language may be included). * extensive laryngeal surgery or other surgery or medical condition that may significantly alter the motor or sensory aspects of the larynx.
a study of bevacizumab (avastin) in combination with chemotherapy in participants with metastatic cancer of the colon or rectum.

Conditions: Colorectal Cancer

Summary: this expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. the anticipated time on study treatment is 3-12 months.


Eligibility criteria:
inclusion criteria: * previously untreated metastatic colon or rectal cancer; * scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment. exclusion criteria: * prior chemotherapy for metastatic colon or rectal cancer; * planned radiotherapy for underlying disease; * central nervous system metastases; * major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.
oxidant status and effect of antioxidant in immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: oxidative stress occurs as a result of increased activity of free radical-producing enzymes, decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants. the most sensitive molecules to oxidation are lipids. loss of cell membrane elasticity, increased cell fragility, and a shortened cellular life span results from oxidation of cell membrane lipids.

free oxygen radicals may have an effect on the structural and functional damage of platelets and plays a role in pathogenesis of thrombocytopenia in both, acute and chronic itp. selenium is an essential mineral found in small amounts in the body. it works as an antioxidant, especially when combined with other antioxidants as vitamin e , a and c. antioxidants neutralize free radicals and may reduce or even help prevent some of the damage they cause. aim of this study is to assess oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (itp) and 6 months later.another aim of the study is to evaluate effect of antioxidant therapy on bleeding score, platelet count and antioxidant status during 6 months follow-up.

Eligibility criteria:
inclusion criteria: * 1. all patients less than 18 years with primary itp; at initial presentation with platelet count less than 40 x 109/l attended ain shams hematology clinic children hospital from january 2013 and followed-up for 6 months. 2. for acute itp, patients will be newly diagnosed (about one month within the diagnosis). 3. for chronic (12-24 months) and persistent (3-12 months) itp patients. exclusion criteria: 1. patients' platelet count more than 40 x 109/l.; or above 18 years 2. patients with secondary cause for thrombocytopenia. 3. patients with any there associated chronic illness affecting oxidant status

Keywords: itp, antioxidant therapy, oxidant status
efficacy of different treatments for obstructive sleep apnea

Conditions: Apnea

Summary: this was a prospective randomized controlled clinical trial that aimed to evaluate the efficacy of three treatments for obstructive sleep apnea osa: 1. conventionally constructed mandibular advancement device (mad). 2. digitally constructed mandibular advancement device (cad cam). 3. uvulopalatopharyngeoplasty (uppp).


Eligibility criteria:
inclusion criteria: * adequate nasal air flow capacity as determined by qualified otolaryngologist * cases showing improvement in airway with mandibular advancement on acoustic pharyngometry (ap) * patients with the minimum component of dentition to support mdsa. * patients with the mandibular protrusive movement of more than 5 mm * body mass index (bmi) less than 30 kg/m2 exclusion criteria: * severe nasal passage obstructions or allergies * obesity (bmi greater than 30 kg/m2 ) * cases with mallampati score greater than class 1 * systemic complications, syndrome, or disease affecting airway * severe periodontal disease
the effect of administration of small doses of thyroxine on glucose and lipid metabolism, in type 2 diabetes mellitus.

Conditions: Diabetes Mellitus

Summary: we investigated the effect of the administration of small doses of thyroxine to healthy humans and patients with type 2 diabetes on postprandial forearm muscle glucose uptake, insulin sensitivity indices, lipid metabolism, in vitro glucose uptake and glut4 recruitment in the plasma membrane of monocytes.

the present open-labeled, randomized and placebo-controlled study was undertaken in euthyroid type 2 diabetic patients and healthy humans, to examine the effect of administration of small doses of thyroxine within the euthyroid range, on muscle glucose disposal, postprandial insulin sensitivity, lipid metabolism, in vitro glucose uptake and glut4 recruitment in the plasma membrane of monocytes.this was investigated with the arteriovenous-difference technique after the consumption of a mixed meal and the in vitro study of a glucose analogue(6-nbdg) uptake by the peripheral monocytes. subjects and methods: eleven euthyroid, treatment naive, type-2 diabetic patients with a micronodular texture of the thyroid gland and eleven healthy euthyroid subjects, were studied before and after administration of 50 μg of thyroxine once daily for 2 months. in parallel, a placebo group was also studied. eleven euthyroid treatment-naïve subjects with type 2 diabetes and a micronodular texture of the thyroid gland, matched for age, sex, bmi, and basal thyroid function, were studied before and after administration of a placebo, once daily for 2 months. experimental protocol: all subjects were admitted to the hospital at 0700 h after an overnight fast and had the radial artery (a) and a forearm deep vein (v) catheterized. a meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein) was given at least 1 h after catheter insertion and was consumed within 20 min. blood samples were drawn from both sites before the meal (at -30 and 0 min) and at 30- to 60-min intervals for 300 min thereafter for measurements of thyroid hormones,glucose, total cholesterol, ldl cholesterol, hdl cholesterol, triglycerides, apolipoprotein a1, apolipoprotein bii and lp(a).forearm blood flow was measured with strain-gauge plethysmography. after the first meal tolerance test, treatment with 50μg of thyroxine or placebo, once daily, was initiated for a 2-month period. then a second identical test was repeated. special care was taken in order to avoid the induction of subclinical hyperthyroidism, that is suppression of tsh below 0.27 μu/ml, as it has recently been shown that the latter is also an insulin-resistant condition.

Eligibility criteria:
inclusion criteria: * healthy or treatment naive type 2 diabetes euthyroid subjects, with a micronodular texture of the thyroid gland. * recreationally active * with stable body weight and diet during the last two months. exclusion criteria: * any systemic disease(besides glucose abnormalities) * any medication therapy * diabetic complications

Keywords: diabetes mellitus, thyroxine
research intervention to support healthy eating and exercise

Conditions: Obesity

Summary: the primary aim of this study is to test the efficacy of a behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds.


Eligibility criteria:
inclusion criteria: * age between 18-75 * bmi between 25-55kg/m2 * all sexes * all racial/ethnic groups * low ses and/or report qualifying for federal, state or local benefits * have a smartphone and willing to use for research purposes exclusion criteria: * \ years of age * report being unable to walk 2 blocks without stopping * are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months * are pregnant or plan to become pregnant within 1 year * report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the physical activity readiness questionnaire * report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines * have diabetes and are on insulin * report a medical condition that could jeopardize their safety in a weight loss program with diet and exercise guidelines * report conditions that, in the judgment of the pi, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in english) * report unable to read and write english

Keywords: weight loss, low income, behavioral economics, contingency management, episodic future thinking, mhealth
benefits of adherence to 5-alpha reductase inhibitor treatment in men with enlarged prostate: an assessment of medicare and medicaid patients using the marketscan database

Conditions: Prostatic Hyperplasia

Summary: adherence and length of treatment with a 5-alpha reductase inhibitor (5ari) therapy may be associated with improved clinical outcomes for patients with enlarged prostates (ep) and lower health care related costs. the objectives of this study are to quantify 1.) the relationship between 5ari adherence and length of therapy and the likelihood of acute urinary retention (aur), prostate-related surgery (emergency and non-emergency), and clinical progression (defined as aur and/or prostate-related surgery); and 2.) the monthly ep-related, medical costs in a medicaid and medicare population. the null hypothesis is that no differences will be observed in the outcomes and costs of patients who adhere to long-term 5ari therapy and those who do not. the test hypothesis is that patients with higher levels of adherence to 5ari for a longer period of time will experience significantly fewer adverse outcomes and significantly lower treatment costs. the data source for this analysis is the marketscan database, which contains medical and pharmacy claims for commercial health plan members and medicare recipients. medical and pharmacy claims data are sourced directly from health plans and employers. the database represents approximately 18 to 20 million individuals annually and nearly 22 million medicaid enrollees from multiple states. the database includes the medicare-covered portion of payment, the employer-paid portion, and any out-of-pocket expenses paid by the beneficiary. the study design is a retrospective cohort analysis. each patient's index date was defined as the date of the first fill for a 5ari prescription.


Eligibility criteria:
inclusion criteria: * male * age 65 or older * a diagnostic claim of bph (icd-9-cm code 222.2x or 600.xx) * a prescription claim for a 5ari for at least 60 days during the observation period * continuous eligibility for 6 months prior to and at least 91 days after the index date exclusion criteria: * a prostate cancer diagnosis * a procedure cost for any prostate-related surgical procedure prior to the index date

Keywords: benign prostatic hyperplasia acute urinary retention adherence 5-alpha reductase inhibitor enlarged prostate surgery
a behavioral intervention to improve work outcomes

Conditions: Mental Disorders

Summary: this research has been designed to learn whether getting regular and specific feedback about work performance with small rewards for meeting goals helps people to improve their job performance and leads to better work outcomes, improved mental functioning, and better quality of life

this study is designed to test whether systematic work performance feedback with weekly goal setting, combined with small rewards given for goal achievement, leads to improved vocational, health, and quality of life outcomes for veterans enrolled in the various work service programs at this medical center. the long-term goal of this project is to determine the effectiveness of these interventions at this medical center and to use this experience for a multi-site cooperative study proposal. research design and methods: one hundred and fifty subjects accepted into work services at this medical center will be randomly assigned to one of two conditions: work feedback with small rewards, or usual services. in the work feedback with small rewards condition, participants attend a weekly workers meeting where they receive specific feedback based upon the work behavior inventory and set weekly goals. they also receive small rewards for goal achievement that equal $10 per month. participants in the usual services condition do not get specific work feedback but receive all the usual work services normally provided. they also receive $10 per month for active participation. assessments include baseline evaluations of mental and physical health, social function, cognitive function, and quality of life. evaluations of mental health, quality of life, and job satisfaction will occur at two months and four months. six-month and twelve month evaluations will repeat the baseline assessment. outcome measures will include biweekly work performance assessments, vocational outcomes, mental and physical health status, social and cognitive function, and quality of life

Eligibility criteria:
inclusion criteria: * veterans participating in a work program at the va connecticut healthcare system; english-speaking exclusion criteria: * no exclusion criteria based upon diagnosis, although va work programs have pre-existing requirements such as a demonstrated need for services, a referral from a clinician, and an interest in work rehabilitation

Keywords: psychotherapy, group rehabilitation, vocational treatment outcome